BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4861692 · Received June 17, 2015

    Report

    Report Number
    4861692
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE OP REPORT THE DEVICE MALFUNCTIONED DUE TO APPARENT FLUID LEAK INTO GENERATOR/ELECTRODE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395426 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR